A Retrospective/Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Hinge Knee (THK) System

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

This study is a prospectively and retrospectively enrolled, post-market, open-label, non-randomized, single institution evaluation of clinical outcomes of primary or revision knee surgery patients who meet the eligibility criteria and received devices from the Triathlon Hinge Knee System according to its indications for use (IFU). Clinical evaluation for all cases will include data collection of patient demographics, surgical details, early postoperative status, functional and clinical outcomes, and survivorship at 1, 2, 6, and 10-years.

Eligibility
Participation Requirements
Sex: All
View:

• The subject undergoes a primary or revision procedure implanting at least the Revision Baseplate portion of the Triathlon Hinge Knee System in accordance with the Indications for Use.

• The subject has signed an IRB/EC-approved, study-specific Informed Consent Form (ICF).

• The subject is a male or non-pregnant female at the time of enrollment.

• The subject agrees to comply with the protocol-mandated clinical evaluations.

Locations
United States
Florida
Cleveland Clinic Florida
RECRUITING
Weston
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Contact Information
Primary
Laura Stiegel
stiegel@ccf.org
216-442-5511
Backup
Sanal Krishnan
krishns11@ccf.org
216-445-7194
Time Frame
Start Date: 2024-05-10
Estimated Completion Date: 2034-05-10
Participants
Target number of participants: 200
Treatments
Primary
Triathlon Hinge Femoral Component + Revision Baseplate
Revision
Triathlon Hinge Femoral Component+ Revision Baseplate
TS Revision
Triathlon TS Femoral Component+ Revision Baseplate
Revision (Maximum of 80 subjects)
Triathlon TS Femoral Component + Revision Baseplate
MRH Revision
MRH Femoral Component + Revision Baseplate
GMRS Primary or Revision
GMRS Femoral Component + Revision Baseplate
Related Therapeutic Areas
Sponsors
Leads: The Cleveland Clinic
Collaborators: Stryker Orthopaedics

This content was sourced from clinicaltrials.gov